Associate Director, Statistical Programming

Psychedelic Alpha; Myrtle Point (OR); Remote; USD 155,000 - 195,000; Full time

Benefits offered by this job

Health benefits

401(k) match

Flexible time off

Parental leave

Job summary

Definium Therapeutics is seeking an Associate Director, Statistical Programming to provide statistical programming support across clinical development, regulatory filings, and commercialization. You will lead study programming, ensure high-quality Define XML packages, and oversee vendor delivery in a fast-paced, work-from-home environment.

Ideal candidates have a Master’s in Biostatistics or related field with 12+ years of clinical trial programming experience, extensive SAS expertise, and

Qualifications

• Master's Degree in Biostatistics, Statistics, Computer Science or other relevant fields with at least 12 years of experience in providing statistical programming support in clinical trial setting.
• Deep understanding about data standards with Pinnacle 21 validation report and creating Define XML packages to support regulatory filing.
• Proficient in statistical computational software such as SAS, including complicated data steps, SAS macro languages, and commonly used analysis procedures (e.g., PROC Freq, PROC REPORT, PROC GLM, and PROC MIXED).
• Demonstrated capacity of collaboration with biostatisticians, Clinical Data Management and colleagues from other functions to deliver common goals.
• Strong organizational and project management skills demonstrated interest in continued learning and growing.
• Proven to work well on multiple projects in a fast-paced environment.
• Detail-oriented and hold high standards of excellence for Statistical Programming’sdeliverables.
• Deliver and communicate effectively in the work-from-home environment.
• Excellent interpersonal skills and a good team player.

Responsibilities

• Serve as the study lead programmer for assigned clinical trial(s), and work closely with study statistician, data management, and other functions within the study team to provide statistical programming support as needed.
• Review and ensure high quality of Define packages including aCRF, SDTM/ADaM datasets, Pinnacle 21 reports, cSDRG/ADRG, and define XML for assigned clinical trial(s).
• Review and ensure high quality of Define packages for integrated datasets from meeting CDISC standards to meeting regulatory requirements as part of electronic submission.
• Work closely with study lead biostatistician to manage vendor’s deliverables from quality to timeline.
• Perform independent validation (QC) to ensure accuracy of statistical vendor’s deliverables from datasets to analytic outputs.
• Perform independent validation (QC) to ensure accuracy of analytic outputs produced by internal biostatisticians or statistical programmers.
• Work closely with Clinical Data Management colleagues to produce systematic data reports to support efficient clinical trial data review and cleaning.
• Review CRF and/or Data Transfer Specification to ensure that data collection will meet the study objectives, requirements, and standards in CDISC format.
• Provide input to Statistical Analysis Plans and TLF Shells for Tables/Listings/Figures.
• Perform statistical analysis to support publications, and/or regulatory correspondence as needed.
• Perform other duties as assigned

Skills

SAS

SAS Macro

Statistical Analysis

CDISC

Define XML

Pinnacle 21

Data Management

Regulatory Filing

Team Collaboration

Project Management

Education

Master's in Biostatistics or related field

Tools

Pinnacle 21

Define XML

SAS

Job description

Definium Therapeutics is a late-stage clinical biopharmaceutical company and our mission is to forge a new era of psychiatry by applying scientific rigor to psychedelics, with the goal of developing accessible treatments that unlock healing at scale.

Our leadproductcandidate,lysergidetartrate(ourproprietary orally disintegrating tablet form oflysergide(LSD) D-tartrate),represents a highly differentiated, potential best-in-class opportunity for patients suffering from generalized anxiety, major depressive disorder, and posttraumatic stress disorder. Our early stage pipeline includes DT402, the R-enantiomer of MDMA and is under development to target the core symptoms of autism spectrum disorder (ASD), specifically addressing social communication challenges.

Guided bythe recognitionthat patients deserve more than better, Definium is relentlessly advancing a new generation of therapeutics intended to addresstheunderlying causes of psychiatric and neurological disorders. By turning evidence into impact, Definium aims to change the trajectory of today’s mental health care crisis and enable a healthier future. Headquartered in New York, Definium Therapeutics trades on Nasdaq under the symbol DFTX.

Together we are moving psychiatry forward—beyond better, into a boundless future. Join us!

As Associate Director, Statistical Programming, this role will provide statistical programming support for compounds at different stages of development, including clinical development, regulatory filing, and commercialization. Reporting to Director, Statistical Programming Lead, this role will serve as the study lead programmer for assigned clinical trial(s), and work closely with study statistician, data management, and other functions within the study team to provide statistical programming support as needed. Working with the study lead biostatistician, this individual will oversee the deliverables from statistical vendors to ensure high quality and meeting timelines. Additionally, this role will perform statistical data analyses and partner with the Clinical Data Management group to support data cleaning activities.

Responsibilities:

• Serve as the study lead programmer for assigned clinical trial(s), and work closely with study statistician, data management, and other functions within the study team to provide statistical programming support as needed
• Review and ensure high quality of Define packages including aCRF, SDTM/ADaM datasets, Pinnacle 21 reports, cSDRG/ADRG, and define XML for assigned clinical trial(s)
• Review and ensure high quality of Define packages for integrated datasets from meeting CDISC standards to meeting regulatory requirements as part of electronic submission
• Work closely with study lead biostatistician to manage vendor’s deliverables from quality to timeline
• Perform independent validation (QC) to ensure accuracy of statistical vendor’s deliverables from datasets to analytic outputs
• Perform independent validation (QC) to ensure accuracy of analytic outputs produced by internal biostatisticians or statistical programmers
• Work closely with Clinical Data Management colleagues to produce systematic data reports to support efficient clinical trial data review and cleaning
• Review CRF and/or Data Transfer Specification to ensure that data collection will meet the study objectives, requirements, and standards in CDISC format
• Provide input to Statistical Analysis Plans and TLF Shells for Tables/Listings/Figures
• Perform statistical analysis to support publications, and/or regulatory correspondence as needed
• Perform other duties as assigned

Qualifications and Skills:

• Master's Degree in Biostatistics, Statistics, Computer Science or other relevant fields with at least 12 years of experience in providing statistical programming support in clinical trial setting
• Deep understanding about data standards with rich experience in understanding Pinnacle 21 validation report and creating Define XML packages to support regulatory filing
• Proficient in statistical computational software such as SAS, including complicated data steps, SAS macro languages, and commonly used analysis procedures (e.g., PROC Freq, PROC REPORT, PROC GLM, and PROC MIXED)
• Demonstrated capacity of collaboration with biostatisticians, Clinical Data Management and colleagues from other functions to deliver common goals
• Strong organizational and project management skills demonstrated interest in continued learning and growing
• Proven to work well on multiple projects in a fast-paced environment
• Detail-oriented and hold high standards of excellence for Statistical Programming’sdeliverables
• Deliver and communicate effectively in the work-from-home environment
• Excellent interpersonal skills and a good team player

Preferred Experience:

• Experience in data structure and data analysis in CNS clinical trials
• Experience in providing integrated data analysis support in regulatory filing

Compensation will be determined based on several factors including, but not limited to, skill set, years of experience, and the employee’s geographic location.

Employees in this role may be entitled to additional compensation, including bonus and equity. Benefits information is listed on our Jobs Page. The Company provides competitive benefits to employees including:

• 100% paid health benefits including Medical, Dental and Vision for you and your dependents
• 401(k) program with company match and vesting after the turn of the first month after your start date
• Flexible time off
• Generous parental leave and some fun fringe perks!

The starting base pay range for this position:

$155,000 - $195,000 USD